Antioxidant dermatological composition

ABSTRACT

Enhanced dermatological compositions are described herein using from about 21 to about 40 wt-% urea with antioxidant skin protectants suitable for the treatment of icthyosis, xerosis, severely dry skin, dermatitis, eczema, debridement and tissue suffering and other similar skin conditions.

FIELD OF THE INVENTION

[0001] This invention relates to a semi-solid composition containingantioxidants and urea for treating and protecting the skin.

BACKGROUND OF THE INVENTION

[0002] As the outermost layer of skin, the stratum corneum (SC) iscontinuously exposed to an oxidative environment, including airpollutants, ultraviolet radiation, chemical oxidants, and aerobicmicroorganisms. Human SC reveals characteristic antioxidant and proteinoxidation gradients with increasing antioxidant depletion and proteinoxidation towards the outer layers. SC antioxidants, lipids, andproteins are oxidatively modified upon treatments with ultravioletA/ultraviolet B, ozone, and benzoyl peroxide. Thiele J. J., SchroeterC., Hsieh S. N., Podda M., Packer L., Curr Probl Dermatol.2001;29:26-42.

[0003] Furthermore, the skin is increasingly exposed to ambientUV-irradiation thus increasing its risk for photooxidative damage withlong term detrimental effects like photoaging, which is characterized bywrinkles, loss of skin tone, and resilience. Scharffetter-Kochanek K,Brenneisen P, Wenk J, et al., Exp Gerontol. 2000; 35:307-316

[0004] The importance of antioxidants is their role in scavenging freeradicals, which are created by natural oxidative process occurring inthe environment.

[0005] There is a need for topical products with antioxidantformulations to prevent UV-induced carcinogenesis and photoaging as wellas to modulate desquamatory skin disorders.

SUMMARY OF THE INVENTION

[0006] Accordingly, the present invention includes an improved treatmentfor the care and protection of the skin, particularly severely dry skin,using a combination of about 21 to about 40 wt-% of urea and about 0.1to 20 wt-% of an antioxidant in a suitable defined formulation.

[0007] Thus, one aspect of the present invention is a dermatologicalcomposition including from about 21 to about 40 wt-% urea, from about0.1 to 20 wt-% of an antioxidant, and the balance being dermatologicallyacceptable excipients.

[0008] The use of such high concentrations of urea combined withantioxidant skin protectants have been found to provide added efficacyand suitability for treating and protecting skin, and, particularly fortreating icthyosis, xerosis, severely dry skin, dermatitis, eczema,debridement and tissue softening as well as other skin conditions.

[0009] Still another aspect of the present invention is a method oftreating xerosis, ichthyosis, severe dry skin, dermatitis, and eczema byapplying to skin in need of treatment an effective amount of asemi-solid dermatological composition containing about 21 to about 40wt-% urea and about 0.1 to 20 wt-% of an antioxidant.

DETAILED DESCRIPTION

[0010] The dermatological composition of the present invention is asemi-solid at room temperature but is easily absorbed into the stratumcorneum. A preferred application of the formulation is a cream whichcontains a petroleum based liquid and solid fraction as skinprotectants.

[0011] The cream composition has advantageous properties for thetreatment of severe dry skin clinically characterized as xerosis and forthe temporary relief of itching associated with various pathologicaldermatological conditions. The formulation produces a keratolytic actionfound beneficial in the treatment of icthyosis, atopic dermatitis. Theformulation also produces added protection against debridement andtissue suffering from oxidative events. Application of the cream to theskin as needed provides relief of the conditions.

[0012] In addition to containing about 21 to about 40 wt-% of urea, thecomposition of the present invention includes an effective amount ofantioxidant skin protectants, for example, from about 0.1 to about 20wt-% based on the total weight of the composition.

[0013] Antioxidants include, but are not limited to, tocopherols(vitamin E), tocopherol derivatives, tocotrienols, ascorbic acid(vitamin C), ascorbic acid derivatives, carotenoids, vitamin A orderivatives thereof, butylated hydroxytoluene, butylated hydroxyanisole,gallic esters, flavonoids such as, for example, quercetin or myricetin,selenium, grape seed extract, catechins such as, for example,epicatechin, epicatechingallate, epigallocatechin orepigallocatechingallate, sulfur-containing molecules such as, forexample, glutathione, cysteine, lipoic acid, N-acetylcysteine, chelatingagents such as, for example, ethylenediamine tetraacetic acid or othercustomary antioxidants.

[0014] One antioxidant, vitamin E, is of particular interest. The term“vitamin E” includes tocopherol (vitamin E) and derivatives thereof suchas, for example, α-, β-, γ-, δ-, ε-, ζ₁, ζ₂, and η-tocopherol, andα-tocopherol acid succinate. Vitamin E is known as an antioxidant andprotective vitamin for phospholipids of the cell membrane. It maintainsthe permeability and stability of the cell membrane, Lucy. Annals N. YAcademy of Science 203, p. 4 (1972). It further has been known thatvitamin E has a membrane-sealing effect. In erythrocytes, the simplestcells of the human body, there has been found that vitamin E provides aprotective effect for the cell membrane. As with all antioxidants,vitamin E protects cells, including, epidermal cells which aresusceptible to a wide range of oxidating events.

[0015] The cream composition also includes a combination of semi-solidand liquid petroleum fractions. The semi-solid skin protectant iscontained in about 5.5 to about 20 wt-% and includes petrolatum or asynthetic or semi-synthetic hydrocarbon of the same nature aspetrolatum. Mixtures of such ingredients can also be used. The preferredsemi-solid material is petrolatum, commercially available from a widevariety of sources.

[0016] The liquid portion skin protectant is a liquid petrolatum andcontained in the composition in about 10 to about 20 wt-%. This materialcan include any synthetic or semi-synthetic oleaginous liquid fraction.A preferred embodiment is mineral oil which is a liquid mixture ofhydrocarbons obtained from petroleum.

[0017] Another preferred ingredient encompassed in the composition ofthe present invention is propylene glycol which may be contained up toabout 5 wt-% in the composition, preferably in the range of from about 1to about 5 wt-%.

[0018] In addition to the above embodiments, the present compositionalso contains dermatologically acceptable excipients, such as forexample emulsifiers and thickeners. Among these are for example a C₁₆ toC₁₈ straight or branched chain fatty alcohols or fatty acids or mixturesthereof. Preferably these include cetyl alcohol, stearyl alcohol,stearic acid, palmitic acid, or mixtures thereof. Fatty acids or fattyalcohols may be present in from about 0.25 to 2 wt-%.

[0019] Another ingredient useful in the composition of the presentinvention may be glyceryl stearate, which is a monoester of glycerineand stearic acid, or other suitable forms of glyceryl stearate forexample glyceryl stearate SE, which is a commercially availableself-emulsifying grade of glycerol stearate that contains some sodiumand/or potassium stearate. Glyceryl stearate may be in the compositionanywhere from about 1 to about 3 wt-%.

[0020] Xanthan gum is another ingredient which may be used in thepresent invention. Xanthan gum is a high molecular weightheteropolysaccharide gum produced by pure-culture fermentation of acarbohydrate with Xanthomonas campestris. The gum is also commerciallyavailable from various sources.

[0021] As part of the dermatologically acceptable excipients, thecomposition includes thickeners which provide a high viscosity creamdesigned to remain in place upon application to the skin. Preferredthickeners include a mixture of a carbomer and triethanolamine. Themixture is combined together and added to the composition in an amounttotaling anywhere from about 0.05 to 5 wt-%. Triethanolamine ispurchased as Trolamine NF from BASF. The carbomers come in variousmolecular weights and identified by numbers. These are otherwise knownas Carbopol. A preferred embodiment of the present invention is Carbopol940. The carbomer or Carbopols are resins which are known thickeningagents. They are homopolymers of acrylic acid crosslinked with an allylether of pentaerythritol, an allyl ether of sucrose or an allyl ether ofpropylene. The carbomer is present in the composition as a thickener andalso is used to suspend and stabilize the emulsion. Although Carbopol940 is preferably used in the present invention, other analogs may alsobe used such as carbomer 910, 2984, 5984, 954, 980, 981, 941 and 934.Carbopol ETD 2001, 2020, and 2050 and Ultrez 20 are also commerciallyavailable and can be used since they are similar in chemistry andfunction.

[0022] A typical formulation representing the particular and mostpreferred embodiment of the present invention is illustrated as follows:Ingredient % W/W Anti-oxidant 5.0 Urea USP 40 Carbopol 940 0.20Petrolatum 6.00 Mineral oil 7.1 Glyceryl stearate 1.86 Cetyl alcohol0.63 Propylene glycol 3.00 Xanthan gum 0.05 Trolamine 0.15 Purifiedwater Q.S. 100.00.

Glossary of Ingredients

[0023] The formulation of the present invention has been defined aboveand more specifically exemplified in the following examples. Since theformulation employs various ingredients, some of the ingredients havebeen defined generically and by common name. In addition, the followingis a glossary of technical names and trade names with manufacturingsources for some of the ingredients employed in the formulation of thepresent invention.

[0024] Mineral Oil

[0025] Definition

[0026] Mineral oil is a liquid mixture of hydrocarbons obtained frompetroleum.

[0027] Technical Names

[0028] Heavy Mineral Oil

[0029] Light Mineral Oil

[0030] Liquid Paraffin

[0031] Paraffin Oil

[0032] Trade Names

[0033] Benol White Mineral Oil (Witco/Sonneborn)

[0034] Blandol White Mineral Oil (Witco/Sonneborn)

[0035] Britol 6 (Witco Corporation)

[0036] Britol 7 (Witco Corporation)

[0037] Britol 9 (Witco Corporation)

[0038] Britol 20 (Witco Corporation)

[0039] Britol 24 (Witco Corporation)

[0040] Britol 35 (Witco Corporation)

[0041] Britol 50 (Witco Corporation)

[0042] Carnation White Mineral Oil (Witco/Sonneborn)

[0043] Crystosol NF 70 (Witco Corporation)

[0044] Crystosol NF 90 (Witco Corporation)

[0045] Crystosol U.S. Pat. No. 200 (Witco Corporation)

[0046] Crystosol U.S. Pat. No. 240 (Witco Corporation)

[0047] Crystosol U.S. Pat. No. 350 (Witco Corporation)

[0048] Drakeol 5 (Penreco)

[0049] Drakeol 6 (Penreco)

[0050] Drakeol 7 (Penreco)

[0051] Drakeol 8 (Penreco)

[0052] Drakeol 9 (Penreco)

[0053] Drakeol 10 (Penreco)

[0054] Drakeol 13 (Penreco)

[0055] Drakeol 15 (Penreco)

[0056] Drakeol 19 (Penreco)

[0057] Drakeol 21 (Penreco)

[0058] Drakeol 32 (Penreco)

[0059] Drakeol 34 (Penreco)

[0060] Drakeol 35 (Penreco)

[0061] Draketex 50 (Penreco)

[0062] Ervol White Mineral Oil (Witco/Sonneborn)

[0063] GloriaWhite Mineral Oil (Witco/Sonneborn)

[0064] Kaydol White Mineral Oil (Witco/Sonneborn)

[0065] Klearol White Mineral Oil (Witco/Sonneborn)

[0066] Parol 70 (Penreco)

[0067] Parol 80 (Penreco)

[0068] Parol 100 (Penreco)

[0069] PD-23 White Mineral Oil (Witco/Sonneborn)

[0070] Peneteck (Penreco)

[0071] Protol White Mineral Oil (Witco/Sonneborn)

[0072] Superla Mineral Oil #5 NF (Amoco Lubricants)

[0073] Superla Mineral Oil #6 NF (Amoco Lubricants)

[0074] Superla Mineral Oil #7 NF (Amoco Lubricants)

[0075] Superla Mineral Oil #9 NF (Amoco Lubricants)

[0076] Superla Mineral Oil #10 NF (Amoco Lubricants)

[0077] Superla Mineral Oil #13 NF (Amoco Lubricants)

[0078] Superla Mineral Oil #18 USP (Amoco Lubricants)

[0079] Superla Mineral Oil #21 USP (Amoco Lubricants)

[0080] Superla Mineral Oil #31 USP (Amoco Lubricants)

[0081] Superla Mineral Oil #35 USP (Amoco Lubricants)

[0082] Uniwhite Oil 55 (UPI)

[0083] Uniwhite Oil 70 (UPI)

[0084] Uniwhite Oil 85 (UPI)

[0085] Uniwhite Oil 130 (UPI)

[0086] Uniwhite Oil 185 (UPI)

[0087] Uniwhite Oil 205 (UPI)

[0088] Uniwhite Oil 350 (UPI)

[0089] Glyceryl Stearate

[0090] Empirical Formula

C₂₁H₄₂O₄

[0091] Definition

[0092] Glyceryl stearate is the monoester of glycerin and stearic acid.It conforms generally to the formula:

[0093] Technical Names

[0094] 2,3-Dihydroxypropyl octadecanoate

[0095] Glyceryl monostearate

[0096] Monostearin

[0097] Octadecanoic acid, 2,3-dihydroxypropyl ester

[0098] Octadecanoic acid, monoester with 1,2,3-propanetriol

[0099] Trade Names

[0100] Aldo HMS (Lonza Inc./Lonza Ltd.)

[0101] Aldo MS (Lonza Inc./Lonza Ltd.)

[0102] Aldo MSLG (Lonza Inc./Lonza Ltd.)

[0103] Alkamuls GMS (Rhone-Poulenc)

[0104] Arlacel 129 (ICI)

[0105] Atmos 150 (ICI)

[0106] Atmul 84 (ICI)

[0107] Atmul 124 (ICI)

[0108] Capmul GMS (Karishamns Lipid Specialties)

[0109] Ceral MN (Fabriquimica)

[0110] Ceral MNT (Fabriquimica)

[0111] Cerasynt GMs (ISP Van Dyk)

[0112] Cerasynt SD (ISP Van Dyk)

[0113] Cithrol GMS N/E (Croda Surfactants Ltd.)

[0114] CPH-53-N (Hall)

[0115] CPH-144-N (Hall)

[0116] Cutina GMS (Henkel)

[0117] Cutina MD (Henkel)

[0118] Cutina MD-A (Henkel)

[0119] Dimodan PM (Grinsted)

[0120] Dimodan PM 300 (Grinsted)

[0121] Elfacos GMS (Akzo BV)

[0122] Emerest 2400 (Henkel/Organic Products)

[0123] Empilan GMS NSE (Albright & Wilson)

[0124] Emuldan FP 40 (Grinsted)

[0125] Emuldan HA 60 (Grinsted)

[0126] Emuldan HLT 40 (Grinsted)

[0127] ESTOL GMS90 1468 (Unichema)

[0128] ESTOL GMSveg 1474 (Unichema)

[0129] Geleol (Gattefosse)

[0130] Grillomuls S 40 (Grillo-Werke)

[0131] Grillomuls S 60 (Grillo-Werke)

[0132] Grillomuls S 90 Grillo-Werke)

[0133] Hefti GMS-33 (Hefti)

[0134] Hefti GMS-99 (Hefti)

[0135] Hodak GMS (Calgene)

[0136] Imwitor 191 (Huls AG/Huls America)

[0137] Imwitor 900 (Huls AG/Huls America)

[0138] Kemester 5500 (Witco)

[0139] Kemester 6000 (Witco)

[0140] Kessco GMS (Akzo BV)

[0141] Lanesta 24 (Lanaetex)

[0142] Lasemul 92 AE (Industrial Quimica)

[0143] Lasemul 92 AE/A (Industrial Quimica)

[0144] Lasemul 92 N 40 (Industrial Quimica)

[0145] Lexemul 503 (Inolex)

[0146] Lexemul 515 (Inolex)

[0147] Lexemul 55G (Inolex)

[0148] Lipo GMS 410 (Lipo)

[0149] Lipo GMS 450 (Lipo)

[0150] Lipo GMS 600 (Lipo)

[0151] Nikkol MGS-DEX (Nikko)

[0152] Norfox GMS (Norman, Fox & Co.)

[0153] Norfvox GMS-SE (Norman, Fox & Co.)

[0154] Prodhybase GLA (Prod'Hyg)

[0155] Protachem 26 (Protameen)

[0156] Protachem G 5509 (Protameen)

[0157] Protachem G-5566 (Protameen)

[0158] Protachem GMS-540 (Protameen)

[0159] Protachem HMS (Protameen)

[0160] Sterol GMS (Auschem)

[0161] Tegin 90 (Goldschmidt)

[0162] Tegin 515 (Goldschmidt)

[0163] Tegin 4011 (Goldschmidt)

[0164] Tegin 4100 (Goldschmidt)

[0165] Tegin GRB (Goldschmidt)

[0166] Tegin ISO (Goldschmidt)

[0167] Tegin M (Goldschmidt)

[0168] Tegin MAV (Goldschmidt)

[0169] Unitina MD (UPI)

[0170] Unitina MD-A (UPI)

[0171] Unitolate GS (UPI)

[0172] Witconol 2400 (Witco)

[0173] Witconol 2401 (Witco)

[0174] Witconol MST (Witco SA)

[0175] Witconol MST (Witco)

[0176] Zohar GLST (Zohar)

[0177] Glyceryl Stearate SE

[0178] Definition

[0179] Glyceryl stearate SE is a self-emulsifying grade of glycerylstearate (q.v.) that contains some sodium and/or potassium stearate.

[0180] Trade Names

[0181] Aldo MSD (Lonza Inc./Lonza Ltd.)

[0182] Ceral ME (Fabriquimica)

[0183] Ceral MET (Fabriquimica)

[0184] Ceral TN (Fabriquimica)

[0185] Cerasynt Q (ISP Van Dyk)

[0186] Cithrol GMS S/E (Croda Surfactants Ltd.)

[0187] Cutina KD-16 (Henkel)

[0188] Dermalcare GMS/SE (Rhone-Poulenc)

[0189] Dracorin GMS SE O/W 2/008475 (Dragoco)

[0190] Emerest 2407 (Henkel/Organic Products)

[0191] Empilan GMS SE (Albright & Wilson)

[0192] Emuldan HA 32/S3 (Grinsted)

[0193] ESTOL BMSse 1462 (Unichema)

[0194] Hefti GMS-33-SES (Hefti)

[0195] Hodag GMS-D (Calgene)

[0196] Imwitor 960 (Huls Ag/Huls America)

[0197] Kemester 6000 SE (Witco)

[0198] Lamecreme KSM (Grunau)

[0199] Lanesta 40 (Lanaetex)

[0200] Lexemul 530 (Inolex)

[0201] Lexemul T (Inolex)

[0202] Lipo GMS 470 (Lipo)

[0203] Mazol GMSD-K (PPG)

[0204] Prodhybase GLN (Prod'Hyg)

[0205] REWOMUL MG SE (Rewo Chemische)

[0206] Tegin (Goldschmidt)

[0207] Tegin Spezial (Goldschmidt)

[0208] Tegin V (Goldschmidt)

[0209] Unitolate GMS-D (UPI)

[0210] Witconol 2407 (Witco)

[0211] Cetyl Alcohol

[0212] Empirical Formula

C₁₆H₃₄O

[0213] Definition

[0214] Cetyl alcohol is the fatty alcohol that conforms generally to theformula:

CH₂(CH₂)₁₄CH₂OH

[0215] Technical Names

[0216] 1-Hexadecanol

[0217] n-Hexadecyl alcohol

[0218] Palmityl alcohol

[0219] Trade Names

[0220] Adol 52 (Witco)

[0221] Adol 520 (Witco)

[0222] Adol 52-NF (Witco)

[0223] Adol 520-NF (Witco)

[0224] Cachalot C-50 (Michel)

[0225] Cachalot C-51 (Michel)

[0226] Cachalot C-52 (Michel)

[0227] Cetaffine (Laserson & Sabetay)

[0228] Cetal (Amerchol)

[0229] Cetyl alcohol (Rhone-Poulenc)

[0230] CO-1695 (Procter & Gamble)

[0231] Crodacol C-70 (Croda, Inc.)

[0232] Crodacol C90 (Croda Chemicals Ltd.)

[0233] Crodacol C-95 (Croda, Inc.)

[0234] Fancol CA (Fanning)

[0235] Hyfatol 16-95 (Aarhus)

[0236] Hyfatol 16-98 (Aarhus)

[0237] Lanette 16 (Henkel)

[0238] Lanol C (SEPPIC)

[0239] Laurex 16 (Albright & Wilson)

[0240] Lipocol C (Lipo)

[0241] Stearic Acid

[0242] Empirical Formula

C₁₈H₃₆O₂

[0243] Definition

[0244] Stearic acid is the fatty acid that conforms generally to theformula:

CH₂(CH₂)₁₆COOH

[0245] Trade Names

[0246] Crosterene SA4310 (Croda Universal Ltd.)

[0247] Dar-Chem 14 (Darling)

[0248] Emersol 120 (Henkel/Emery)

[0249] Emersol 132 (Henkel/Emery)

[0250] Emersol 150 (Henkel/Emery)

[0251] Glycon DP (Lonza Inc./Lonza Ltd.)

[0252] Glycon P-45 (Lonza Inc./Lonza Ltd.)

[0253] Glycon S-65 (Lonza Inc./Lonza Ltd.)

[0254] Glycon S-70 (Lonza Inc./Lonza Ltd.)

[0255] Glycon S-90 (Lonza Inc./Lonza Ltd.)

[0256] Glycon TP (Lonza Inc./Lonza Ltd.)

[0257] Hy-Phi 1199 (Darling)

[0258] Hy-Phi 1303 (Darling)

[0259] Hy-Phi 1401 (Darling)

[0260] Hystrene 4516 (Witco)

[0261] Hystrene 5016 (Witco)

[0262] Hystrene 7018 (Witco)

[0263] Hystrene 9718 (Witco)

[0264] Industrene 5016 (Witco)

[0265] Industrene 7018 (Witco)

[0266] Kartacid 1890 (Akzo BV)

[0267] Neo-Fat 18 (Akzo)

[0268] Neo-Fat 18-54 (Akzo)

[0269] Neo-Fat 18-55 (Akzo)

[0270] Neo-Fat 18-61 (Akzo)

[0271] Pearl Stearic (Darling)

[0272] PRIFAC 2981 (Unichema)

[0273] Pristerene 4900 (Unichema)

[0274] Pristerene 4901 (Unichema)

[0275] Pristerene 4902 (Unichema)

[0276] Pristerene 4904 (Unichema)

[0277] Pristerene 4905 (Unichema)

[0278] Pristerene 4910 (Unichema)

[0279] Pristerene 4911 (Unichema)

[0280] Pristerene 4915 (Unichema)

[0281] Pristerene 4921 (Unichema)

[0282] Pristerene 4968 (Unichema)

[0283] Pristerene 9550 (Unichema)

[0284] Safacid 18 (Pronova)

[0285] Safacid 16/18 CR (Pronova)

[0286] Unifat 54 (UPI)

[0287] Unifat 55L (UPI)

[0288] Stearyl Alcohol

[0289] Empirical Formula

C₁₈H₃₈O

[0290] Definition

[0291] Stearyl alcohol is the fatty alcohol that conforms generally tothe formula:

CH₃(CH₂)₁₆CH₂OH

[0292] Technical Name

[0293] 1-Octadecanol

[0294] Trade Names

[0295] Adol 63 (Witco)

[0296] Adol 61-NF (Witco)

[0297] Adol 62-NF (Witco)

[0298] Adol 620-NF (Witco)

[0299] Cachalot S-53 (Michel)

[0300] Cachalot S-54 (Michel)

[0301] Cachalot S-56 (Michel)

[0302] CO-1895 (Procter & Gamble)

[0303] Crodacol S-70 (Croda, Inc.)

[0304] Crodacol S-95 (Croda, Inc.)

[0305] Crodacol S-95 (Croda Chemicals Ltd.)

[0306] Fancol SA (Fanning)

[0307] Hyfatol 18-95 (Aarhus)

[0308] Hyfatol 18-98 (Aarhus)

[0309] Lanette 18 (Henkel)

[0310] Lanol S (SEPPIC)

[0311] Laurex 18 (Albright & Wilson)

[0312] Lipocol S (Lipo)

[0313] Stearal (Amerchol)

[0314] Stearyl Alcohol (Rhone-Poulenc)

[0315] Steraffine (Laserson & Sabetay)

[0316] Unihydag WAX-18 (UPI)

[0317] Palmitic Acid

[0318] Empirical Formula

C₁₆H₃₂O₂

[0319] Definition

[0320] Palmitic acid is the fatty acid that conforms generally to theformula:

CH₃(CH₂)₁₄COOH

[0321] Technical Name

[0322] n-Hexadecanoic acid

[0323] Trade Names

[0324] Crodacid PD3160 (Croda Universal Ltd.)

[0325] Edenor L2SM (Henkel)

[0326] Emersol 142 (Henkel/Emery)

[0327] Emersol 144 (Henkel/Emery)

[0328] Hystrene 7016 (Witco)

[0329] Hystrene 9016 (Witco)

[0330] Kartacid 1692 (Akzo BV)

[0331] Neo-Fat 16 (Akzo)

[0332] Neo-Fat 16-54 (Akzo)

[0333] Neo-Fat 16-56 (Akzo)

[0334] Neo-Fat 16-S (Akzo)

[0335] PRIFAC 2962 (Unichema)

[0336] Prifrac 2690 (Unichema)

[0337] Trade Name Mixture

[0338] N.S.L.E. (Sederma)

[0339] Propylene Glycol

[0340] Empirical Formula

C₃H₈O₂

[0341] Definition

[0342] Propylene glycol is the aliphatic alcohol that conforms generallyto the formula:

[0343] Technical Name

[0344] 1,2-Propanediol

[0345] Trade Names

[0346] Lexol PG-865 (855) (Inolex)

[0347] 1,2-Propylene Glycol USP (BASF)

[0348] Xanthan Gum

[0349] Definition

[0350] Xanthan gum is a high molecular weight hetero polysaccharide gumproduced by a pure-culture fermentation of a carbohydrate withXanthomonas campestris.

[0351] Technical Names

[0352] Corn sugar gum

[0353] Xanthan

[0354] Trade Names

[0355] Kelgum CG (Calgon)

[0356] Keltrol (Kelco)

[0357] Keltrol CG (Calgon)

[0358] Keltrol CG 1000 (Calgon)

[0359] Keltrol CG BT (Calgon)

[0360] Keltrol CG F (Calgon)

[0361] Keltrol CG GM (Calgon)

[0362] Keltrol CG RD (Calgon)

[0363] Keltrol CG SF (Calgon)

[0364] Keltrol CG T (Calgon)

[0365] Keltrol CG TF (Calgon)

[0366] Kelzan (Kelco)

[0367] Merezan 8 (Meer)

[0368] Merezan 20 (Meer)

[0369] Rhodigel (Vanderbilt)

[0370] Rhodigel (Rhone-Poulenc)

[0371] Rhodopol SC (Rhone-Poulenc)

[0372] Xanthan gum (Jungbunzlauer)

[0373] Triethanolamine

[0374] Empirical Formula

C₆H₁₅O₃N

[0375] Definition

[0376] Triethanolamine is an alkanolamine that conforms generally to theformula:

N(CH₂CH₂OH)₃

[0377] Technical Names

[0378] Ethanol, 2,2′,2″-Nitrilotris-2,2′,2″-Nitrilotris[Ethanol]

[0379] TEA

[0380] Trolamine

[0381] Trade Name

[0382] Triethanolamine Pure C (BASF)

EXAMPLE

[0383] The typical formulation illustrated above is preparedcommercially as follows: # Ingredient Batch Units 1 Purified water1084.47 Gm 2 Vitamin E 150.00 Gm 3 Urea USP 1200.00 Gm 4 Carbopol 9404.50 Gm 5 Petrolatum 178.20 Gm 6 Mineral oil 211.80 Gm 7 Glycerylstearate 56.25 Gm 8 Cetyl alcohol 18.78 Gm 9 Propylene glycol 90.00 Gm10  Xanthan gum 1.50 Gm 11  Trolamine NF 4.50 Gm 12  Purified Water Q.S.3000.00 Gm

[0384] The above product was manufactured as follows:

[0385] Step 1

[0386] Place #1 in Tank A (water phase) and sprinkle in #4 in Tank A andmix to disperse. After uniformly dispersed, heat contents of Tank A toabout 75° C. while mixing.

[0387] Step 2

[0388] Add #3 to Tank A and mix to dissolve.

[0389] Step 3

[0390] In a separate tank add #2, 5, 6, 7, 8. Heat to about 75° C. withmixing (oil phase).

[0391] Step 4

[0392] In a separate container disperse uniformly #10 in #9. Add this toTank A and continue to mix.

[0393] Step 5

[0394] Add the oil phase (step 3) to the water phase in Tank A withmixing.

[0395] Step 6

[0396] Add #11 to Tank A and mix. Slowly cool the batch.

[0397] Step 7

[0398] Add #12 to Q.S. the batch to final weight.

[0399] The bulk product is then packaged into conventional containersfor use as a cream.

We claim:
 1. A dermatological composition comprising: (a) about 21 to about 40 wt-% urea; (b) about 0.1 to 20 wt-% of an antioxidant, and the balance being dermatologically acceptable excipients.
 2. The composition of claim 1, where the antioxidant selected from the group of tocopherols and derivatives thereof, tocotrenols, ascorbic acid and derivatives thereof, selenium, grape seed extract, carotenoids, vitamin A or derivatives thereof, butylated hydroxytoluene, butylated hydroxyanisole, gallic esters, flavonoids, catechins, glutathione, cysteine, lipoic acid, N-acetylcysteine, ethylenediamine tetraacetic acid and mixtures thereof
 3. The composition of claim 1, where the antioxidant is vitamin E.
 4. The composition of claim 1, wherein the antioxidant is vitamin C.
 5. The composition of claim 2, where the antioxidant is grape seed extract.
 6. The composition of claim 1, wherein the excipients comprise skin protectants of an oleaginous nature derived from petroleum, emulsifiers and thickeners.
 7. The composition of claim 6, wherein the skin protectants are a mixture of a semi-solid petrolatum or a synthetic or semi-synthetic hydrocarbon or a mixture thereof, and a liquid petrolatum or a synthetic or semi-synthetic oleaginous liquid derivative thereof, or a mixture thereof.
 8. The composition of claim 7, wherein the semi-solid petrolatum is present in an amount from about 5.5. to about 20 wt-%.
 9. The composition of claim 1, which further comprises up to 5 wt-% of propylene glycol.
 10. The composition of claim 1, in the form of a semi-solid at room temperature.
 11. The composition of claim 1, which further comprises a mixture of a carbomer and triethanolamine in a total amount from about 0.05 to about 30 wt-%.
 12. The composition of claim 1, in the form of a viscous cream, gel or lotion.
 13. A method of treating and protecting dry skin comprising applying to skin in need thereof an effective amount of a composition according to claim
 1. 14. A method of treating xerosis, icthyosis and severely dry skin comprising applying to skin in need of such treatment an effective amount of a composition according to claim
 1. 